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The Critical Path Program in Taiwan

  • Good Regulatory Science in Asia/Pacific: Part 2
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Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

Taiwan’s Critical Path Program facilitates the development process for niche products of new drug and medical devices. The program fosters a favorable regulatory environment by establishing guidance systems and identifying selected index cases for successful stories through achievement-based proactive consultation. A total of 27 index cases were selected from a total of 68 cases submitted. Two index cases have been terminated due to poor results. Five index cases have been ended with milestones achieved. In 2008, 21 index cases were actively in operation. Nine of them have advanced from the preclinical stage to the clinical stage. The proactive consultation mechanism, rolling review, impact on funding mechanisms, milestone achievement, and customer satisfaction feedback of this program are described in this article.

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Authors and Affiliations

  1. Center for Drug Evaluation, Taipei, Taiwan

    Bing Bing Lin PhD, EMBA (Principal Researcher, Adjunct Assistant Professor)

  2. Department of Business Administration and Department of Healthcare Management, Chang Gung University, Tao Yuan, Taiwan

    Bing Bing Lin PhD, EMBA (Principal Researcher, Adjunct Assistant Professor)

  3. Division of Resource Development, Center for Drug Evaluation, Taipei, Taiwan

    Chih-Hwa Lin PhD (Director)

  4. Center for Drug Evaluation, 1F, No. 15-1, Sec. 1, Hangjou S. Rd., Taipei, 100, Taiwan

    Herng-Der Chern MD, PhD (Executive Director)

Authors
  1. Bing Bing Lin PhD, EMBA
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  2. Chih-Hwa Lin PhD
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  3. Herng-Der Chern MD, PhD
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Corresponding author

Correspondence to Herng-Der Chern MD, PhD.

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Lin, B., Lin, CH. & Chern, HD. The Critical Path Program in Taiwan. Ther Innov Regul Sci 43, 311–317 (2009). https://doi.org/10.1177/009286150904300310

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  • DOI: https://doi.org/10.1177/009286150904300310

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